Principal Regulatory Affairs Specialist

Stryker Corporation Honolulu , HI 96812

Posted 2 months ago

Job Description:

Stryker is one of the world's leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. The Company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives. We are currently seeking a Principal Regulatory Affairs Specialist to join our Endsoscopy division in San Jose, CA or remotely anywhere within the US.

Who we want

  • Strategic thinkers. People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities.

  • Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.

  • Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.

  • Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.

What you will do:

As the Principal Regulatory Affairs Specialist, you will support the Manager of Regulatory in developing a partnership with other departments in designing and enhancing regulatory initiatives to facilitate overall regulatory compliance.

  • Participate in and support product development teams for new and continuing projects.

  • Assist in the review of documentation, protocols and reports received; and prepares additional written materials as needed.

  • Prepare US and OUS regulatory submissions required for approval or registrations, including 510(k)s, Memos to 510(k) files, Technical Files, Design Dossier, and other regulatory submissions as applicable.

  • Prepare responses to FDA letters, supplements, and amendments.

  • Review and approve product and process changes and labeling materials according to regulations.

  • Write Standard Operating Procedures (SOPs) as needed to comply with the regulations.

  • Keep apprised of new regulations, standards, policies, and guidance issued by relevant regulatory authorities that may impact the company.

What you need:

  • A Bachelor's degree in Engineering, Biological Sciences or equivalent focus required.

  • A minimum of 9 years of working in a FDA regulated industry.

  • A minimum of 7 years of Regulatory Affairs experience required.

  • Previous experience with Class II / III Medical Devices preferred.

  • RAC certification or Advanced Degree (Masters in Regulatory Affairs) preferred.

  • Ability to understand and explain detailed regulatory compliance programs and/or issues.

  • Ability to comply with constantly changing regulatory procedures and prioritize work effectively.

  • Ability to analyze and resolve non-routine regulatory issues using independent judgment.

  • Excellent analytical and writing skills.

  • Excellent interpersonal, written and oral communication skills.

  • Effective organizational skills.

  • Advanced PC skills with proficiency in Microsoft office Suite, including Excel.

Work From Home: Remote

Travel Percentage: Up to 25%

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.

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Principal Regulatory Affairs Specialist

Stryker Corporation